ID

26107

Description

Randomised, open label, two period, crossover study to compare the steroid systemic exposure of Fluticasone Propionate (FP) from FP/Salmeterol (SALM) (500/50) DISKUS and Budesonide (BUD) from BUD/formoterol (FOR).(200/6) Turbuhaler in patients with severe Chronic Obstructive Pulmonary Disease. Primary objective:To compare the exposure of the inhaled steroid fluticasone propionate (FP) and budesonide following repeat dosing with SERETIDE DISKUS (500/50) one inhalation twice daily (b.i.d.) when compared with Symbicort Turbuhaler (200/6) two inhalations b.i.d. in a severe chronic pulmonary obstructive disease (COPD) population. Secondary objectives:To compare the pharmacokinetics of FP and budesonide following repeat dosing with SERETIDE DISKUS (500/50) one inhalation b.i.d. when compared with Symbicort Turbuhaler (200/6) two inhalations b.i.d. in a severe COPD population and to explore further the pharmacokinetics of FP and budesonide.

Keywords

Versions (1)
  1. 10/9/17 10/9/17 -
Copyright Holder

Glaxo Smith Kline

Uploaded on

October 9, 2017

DOI

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License

Creative Commons BY-NC 3.0
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GSK Study ID 100807 Fluticasone Propionate from SERETIDE™ (500/50) DISKUS™ and Budesonide from Symbicort (200/6) Turbuhaler in patients with severe Chronic Obstructive Pulmonary Disease. End of Study Record

English

End of Study Record

1 forms  
  1. StudyEvent: ODM
    1. End of Study Record
End of Study Record
Description

End of Study Record

Alias
UMLS CUI-1
C0008976
UMLS CUI-2
C0444930
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date of subject completion or discontinuation from the study
Description

Date of subject completion or discontinuation from the study

Data type

date

Alias
UMLS CUI [1,1]
C2348577
UMLS CUI [1,2]
C0011008
Time of subject completion or discontinuation from the study
Description

Time of subject completion or discontinuation from the study

Data type

time

Alias
UMLS CUI [1,1]
C2348577
UMLS CUI [1,2]
C0040223
Did the subject become pregnant during the study?
Description

If YES, record details on PREGNANCY NOTIFICATION FORM.

Data type

text

Alias
UMLS CUI [1]
C0032961
Did the subject discontinue the study prematurely?
Description

premature discontinuation of study

Data type

boolean

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C2348568
Primary reason for premature discontinuation
Description

premature discontinuation of study

Data type

text

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C2348568
Specify other reason for discontinuation
Description

Other reason for discontinuation

Data type

text

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C3840932
Investigator Comment Log
Description

Investigator Comment Log

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C0947611
Date of comment
Description

Date of comment

Data type

date

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0011008
CRF page number if applicable
Description

page number

Data type

integer

Alias
UMLS CUI [1]
C1704732
Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
I confirm that I have carefully examined all entries on the Screening Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, correct as of the date below.
Description

Investigator's Statement

Data type

boolean

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C1710187
Date of completion
Description

Date of completion

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0850287
Investigators signature
Description

Investigators signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Investigators name-print
Description

Investigators name

Data type

text

Alias
UMLS CUI [1]
C2826892
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Similar models

End of Study Record

1 forms
  1. StudyEvent: ODM
    1. End of Study Record
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
End of Study Record
C0008976 (UMLS CUI-1)
C0444930 (UMLS CUI-2)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Date of subject completion or discontinuation from the study
Item
Date of subject completion or discontinuation from the study
date
C2348577 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of subject completion or discontinuation from the study
Item
Time of subject completion or discontinuation from the study
time
C2348577 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Did the subject become pregnant during the study?
text
C0032961 (UMLS CUI [1])
Pregnancy
Code List
Did the subject become pregnant during the study?
CL Item
No (N)
CL Item
Not Applicable (not of childbearing potential or male) (X)
CL Item
Yes (Y)
premature discontinuation of study
Item
Did the subject discontinue the study prematurely?
boolean
C0457454 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Item
Primary reason for premature discontinuation
text
C0457454 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
premature discontinuation of study
Code List
Primary reason for premature discontinuation
CL Item
Adverse event (A)
CL Item
Consent withdrawn (C)
CL Item
Lost to follow up (L)
CL Item
Protocol violation (P)
CL Item
Other (X)
Other reason for discontinuation
Item
Specify other reason for discontinuation
text
C0457454 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
Item Group
Investigator Comment Log
C0008961 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
Date of comment
Item
Date of comment
date
C0947611 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
page number
Item
CRF page number if applicable
integer
C1704732 (UMLS CUI [1])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Investigator's Statement
Item
I confirm that I have carefully examined all entries on the Screening Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, correct as of the date below.
boolean
C0008961 (UMLS CUI [1,1])
C1710187 (UMLS CUI [1,2])
Date of completion
Item
Date of completion
date
C0011008 (UMLS CUI [1,1])
C0850287 (UMLS CUI [1,2])
Investigators signature
Item
Investigators signature
text
C2346576 (UMLS CUI [1])
Investigators name
Item
Investigators name-print
text
C2826892 (UMLS CUI [1])
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